Pilot Study of Wearable Artificial Kidney

Preliminary Study to Assess the Safety and Efficacy of a Wearable Artificial Kidney Device for the Treatment of Patients With Endstage Renal Failure

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00454974

Acronym

WAK

Enrollment

Registered

2007-04-02

Start date

2007-03-31

Completion date

2007-03-31

Last updated

2007-04-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Renal Failure

Keywords

end stage renal failure, dialysis, wearable artificial kidney

Brief summary

This is a pilot study of a wearable type of kidney dialysis machine to treat patients with chronic kidney disease.

Detailed description

This is a pilot study to evaluate the clearances, tolerability and safety of a wearable artificial kidney device for treating patients with chronic kidney failure.

Interventions

DEVICEWearable artificial kidney

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

* End stage renal failure * Regular haemodialysis * Cardiovascular stability * Stable vascular access

Exclusion criteria

* Allergy to heparin or ethylene oxide * Recent cardiovascular or neurological event * Unable to provide informed consent * Age \< 18

Design outcomes

Primary

Measure	Time frame
urea, potassium, phosphate and B2M clearances	—
safety - cardiovascular,no hemolysis, bleeding, infection	—
no ammonia generation from sorbents, control of acid base balance	—

Secondary

Measure	Time frame
fluid removal	—
patient satisfaction questionnaire	—
affect of treatment of cytokines	—

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026